MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD-MORREY TOTAL ELBOW; PROSTHESIS, ELBOW, CONSTRAINED

Catalog Number	32810502704
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an elbow revision approximately two (2) years and seven (7) months post-implantation due to loosening of the humeral component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# unk ulnar component; lot# unknown; item# unk bushing; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; b7; d2; d10; g1; g3; g6; h1; h2.D10: item# 32810504301; lot# 64662236.Item# 110034365; lot# 918aak1906.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.H6: proposed component code - mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-revision office visit notes - prior radiographic loosening, pain in upper arm, distal half, right where implant is located.Assessment: mild swelling, mild global tenderness, rom 45-110 with pain at end ranges.X-rays: lucent line around cement mantle of humeral component, no osteolysis, no involucrum or sequestrum.Nuclear medicine study: increased reuptake consistent with loosening of humeral component.Ulnar component has some increased uptake near the hinge but distally into shaft there is not much.The radial head does have the expected uptake from the recent fracture.Revision notes - indication: loosening & pain.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed through medical records.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COONRAD-MORREY TOTAL ELBOW
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21366022
• Report Number: 0001822565-2025-00345
• Device Sequence Number: 18255914
• Product Code: JDC
• UDI-Device Identifier: 00889024274006
• UDI-Public: (01)00889024274006(17)250131(10)64449972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 32810502704
• Device Lot Number: 64449972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 06/19/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/18/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG